vTv Therapeutics’ Phase 2 diabetes trial meets primary objective

vTv Therapeutics’ (NASDAQ:VTVT) Phase 2 trial of TTP399 in Type 1 diabetes (T1D) patients met its primary objective by demonstrating statistically significant improvements in HbA1c compared to placebo.

The company reported positive results from the second part of the study, which enrolled 85 T1D patients using insulin pumps and continuous glucose monitoring. 

Treatment-complaint patients who did not administer increases of bolus insulin of three or more units per day achieved a statistically significant placebo-subtracted reduction in HbA1c of 0.32%.

“I am very pleased that Part 2 of the study confirmed the positive results and effects we saw in Part 1,” Dr. John Buse, the study’s principal investigator, said in a statement.

“A once-a-day pill that reduces HbA1c and improves time in range with continuous glucose monitoring, without increasing hypoglycemia or any signal for adverse events, is a big win for the future care of type 1 diabetes,” he added.

vTv reported positive results from the first part of the study, which enrolled 19 T1D patients, in June 2019. The company plans to initiate a Phase 3 trial later this year.

Steve Holcombe, vTv’s president and CEO, commented, “Consistent with FDA guidance, a 0.3% improvement in HbA1c is considered clinically meaningful, and coupled with the well-controlled population of patients and favorable safety data from our clinical trials to date, this provides a strong basis for moving this potential first-in-class program forward.”